Brain TumorPhase 2MemoryRTNCT07470606
Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the Brain
A Phase 2 study testing Memantine and Raloxifene in people with Brain Tumor, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The study investigators are testing to see if patients receiving radiation treatment for brain cancer along with raloxifene plus memantidine take longer to develop memory issues. The study will include anyone over the age of 18 who will be treated with radiation for brain cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Memantine and Raloxifene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2026to Jul 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Ability to provide informed written consent in either English or Spanish.
- All individuals of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an Intrauterine device (IUD)) with their partner from entry into the study through 24 weeks after the last dose of Raloxifene.
- Patients undergoing radiation therapy to the brain as a part of solid tumor cancer therapy, using intensity modulated radiation therapy (IMRT) or whole brain radiation therapy (WBRT).Willingness to adhere to planned study drug regimen, including obtaining medication from an outside pharmacy via prescription.
- Patients must have a creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault Equation).
- Patients must not have hepatic impairment greater than Child-Pugh Score "Class A".
Who cannot join
- History of prior radiotherapy to the brain.
- Life expectancy of < 6 months.
- Radiation Therapy planned is ≤ 5 fractions (e.g.stereotactic radiosurgery (SRS)or Steriotactic radiotherapy (SRT), or 5-fraction whole brain).
- Contraindications to taking memantine and/or raloxifene based on package inserts and the clinical judgement of the treating physician .
- The subject is unable to undergo magnetic resonance imaging (MRI) scan (e.g., has an MRI incompatible pacemaker).
- Conditions or situations which, in the opinion of the investigator, imply the patient will be unable or not suitable to complete trial requirements or at excessive risk from trial participation.
- Known allergy to either of the medications (Memantine or Raloxifene) used in this study or their excipients.
- Cognitive failure as assessed by Mini Mental State Exam (MMSE) score <17
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, 78229
Kayla Chamberlin, 210-450-5964, chamberlink@uthscsa.edu
Andrew J Brenner, MD, PhD
About this study
Official title: Memory RT: Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the Brain
The study investigators are testing to see if patients receiving radiation treatment for brain cancer along with raloxifene plus memantidine take longer to develop memory issues.
The study will include anyone over the age of 18 who will be treated with radiation for brain cancer.
Read the detailed description
As cognitive decline is a common side effect after external beam radiation therapy to the brain, estrogen receptor beta (ERβ) modulation presents an unexploited target for mitigating this adverse effect as well.
The investigators seek to address two scientific questions to improve quality of life in patients and improve cancer outcomes: 1) can estrogen modulation further augment neuroprotection achieved by memantine after radiation therapy to the brain? and 2) can estrogen modulation lead to measurable tumor control improvement and molecular changes in CNS malignancies?
- Conditions
- Brain Tumor
- Being tested
- Memantine, Raloxifene
- Keywords
- Radiation therapy, Solid tumor cancer, Intensity modulated radiation therapy (IMRT)
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Namenda
The goal dose for Immediate Release Memantine is 10 mg oral twice daily. The goal-dose for Extended-Release Memantine is 21 mg daily.
RaloxifeneDrug
Also called Evista
Raloxifene will be administered at 120mg orally every day
| Study group | Role | What they receive |
|---|---|---|
| Group A: Standard of Care | Active comparator | Patients will start Memantine as SOC around the time of radiation. Memantine may be continued as SOC as prescribed by the treating physician after the 24 weeks. Receives: Drug: Memantine |
| Group B: Standard of Care plus raloxifene | Experimental | Patients will start Memantine as SOC around the time of radiation. Memantine may be continued as SOC as prescribed by the treating physician after the 24 weeks.
If randomized to group B patients will be recommended to start the assigned Raloxifene at least one week before their anticipated RT treatment start date. Receives: Drug: Memantine; Drug: Raloxifene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hippocampal volume changes
MRIs will be used to capture any changes in hippocampal volume
Measured: Baseline to 48 weeks
Secondary outcomes (12)
Eastern Cooperative Oncology Group Performance Status score
A 0-5 scale to assess a cancer patient's functional ability showing how their daily life is impacted by the disease. A score of 0 means fully active, while a higher score indicates increasing disability with 5 indicating death.
Measured: Baseline to study termination visit (approximately 48 weeks)
Hopkins Verbal Learning Test Revised (HLVT-R) Score
HVLT-R scoring involves summing words recalled in learning trials for Total Recall, calculating Percentage Retention (Delayed Recall / Higher of Trials 2/3), and determining the Recognition Discrimination Index (True Positives - False Positives). These raw scores are then converted to age-adjusted T-scores, which are compared to normative data (16-92 years old) to assess verbal learning and memory in brain-disordered populations, with higher scores generally indicating better performance.
Measured: Week 0 to study termination visit (approximately 48 weeks)
Trail Making Test -A (TMT-A) Score
A neuropsychological number test measuring psychomotor speed and visual attention by connecting numbers (1-25) in sequence. Higher scores (more time) indicate greater impairment, with averages around 29 seconds, while scores over 30-40 seconds often suggest potential cognitive issues, though norms vary by age and education.
Measured: Week 0 to study termination visit (approximately 48 weeks)
Trail Making Test -B (TMT-B) Score
A neuropsychological number and letter test measuring psychomotor speed and visual attention by connecting numbers (1-25) in sequence. Higher scores (more time) indicate greater impairment, with averages around 75 seconds, while scores over 273 second often suggest potential cognitive issues, though norms vary by age and education.
Measured: Week 0 to study termination visit (approximately 48 weeks)
Controlled Oral Word Association (COWA) Test Score
A neuropsychological test assessing verbal fluency and executive functions like self-initiation, requiring a person to name as many words as possible starting with a specific letter (like F, A, S, or C, F, L) within 60 seconds, for three trials, while avoiding repetitions, proper nouns, or variations of the same word root to gauge cognitive health, especially after brain injury or with conditions like dementia. The score includes the total number of unique, correct words across the trials. A higher score indicated better cognitive function.
Measured: Week 0 to study termination visit (approximately 48 weeks)
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Brain (BN)tumor-20
A 20 item questionnaire with each item scored from 0-4 with a total possible score of 0-80. A higher score indicates a worse quality of life.
Measured: Week 0 to study termination visit (approximately 48 weeks)
MD Anderson Symptom Inventory Brain Tumor (MDASI-BT)
Involves rating 23 symptoms and 6 interference items on a 0-10 scale (0=not present/did not interfere, 10=as bad as you can imagine/interfered completely) for the last 24 hours, calculating mean scores for overall symptoms, symptom factors (like neurological, cognitive, GI), and interference (activity/mood), with scores of 5 or greater indicating moderate-to-severe symptoms. Scores are averaged for summary measures, providing a picture of symptom burden and its impact on daily life for brain tumor patients. A mean of the total score is calculated with a higher score indicating worse symptoms.
Measured: Week 0 to study termination visit (approximately 48 weeks)
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
A total of 50 items are included that cover the following domains of Quality of life (QOL): physical well-being, social/family well-being, emotional well-being, functional well-being, and disease specific concerns. Patients are asked to indicate the presence/severity of certain issues/symptoms on a scale of 0 - 4 (a 5-point Likert Scale).The range of scores is 0-148 with a higher indicating a better quality of life.
Measured: Week 0 to study termination visit (approximately 48 weeks)
Medical Outcomes Study - Cognitive Function (MOS-CF)
The Medical Outcomes Study Cognitive Functioning Scale is a patient-reported measure of perceived cognitive functioning consisting of six items that assess the frequency of problems with concentration, reasoning, confusion, forgetfulness, and mental clarity during the previous four weeks. Each item is scored on a 6-point Likert scale ranging from 1 ("all of the time") to 6 ("none of the time"), where higher values indicate fewer cognitive difficulties. Item scores are summed to generate a raw total score ranging from 6 to 36, with higher scores reflecting better cognitive functioning and fewer reported cognitive problems, and lower scores indicating greater perceived impairment. In some studies the raw score is also linearly transformed to a 0-100 scale, where 0 represents the worst cognitive functioning and 100 represents the best cognitive functioning.
Measured: Week 0 to study termination visit (approximately 48 weeks)
Patient Reported Outcomes Measurement Information System - Cognitive Function (PROMIS-CF)
The PROMIS-CF score is derived from two items: (1) My memory has been as good as usual and (2) I have been able to focus my attention, which ask patients to self-report on their cognitive abilities with the following response scale: 1 = Not at all, 2 = A little bit, 3 = Somewhat; 4 = Quite a bit, and 5 = Very much. Total scores are from 1-10 with a higher score indicating better cognitive function.
Measured: Week 0 to study termination visit (approximately 48 weeks)
Hopkins Verbal Learning Test Revised HLVT-R DR
Hopkins Verbal Learning Test-Revised Delayed Recall is a neuropsychological test assessing verbal memory by having individuals recall a list of 12 words after a delay (around 20-25 minutes). Scoring is from 0-12 with a higher score indicating better recall.
Measured: Week 0 to study termination visit (approximately 48 weeks)
Hopkins Verbal Learning Test Revised HLVT-R RECOG
The Hopkins Verbal Learning Test-Revised recognition discrimination index is a component of the HVLT-R that evaluates verbal recognition memory following presentation of a 12-word learning list. After the delayed recall phase, participants complete a recognition trial consisting of 24 items (the 12 original target words mixed with 12 distractor words). For each item, the respondent indicates whether the word was part of the original list (yes/no). Scoring is based on the Recognition Discrimination Index (RDI), calculated as the number of correct recognitions (hits) minus the number of incorrect endorsements of distractors (false positives). The resulting score ranges from -12 to +12, with higher scores indicating better recognition memory and greater ability to discriminate target words from distractors, while lower scores reflect poorer recognition performance and greater memory impairment.
Measured: Week 0 to study termination visit (approximately 48 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start6 Jul 2026
- Primary completionJul 2030 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Single-Institution, Open-Label, Prospective, 2-Group (R+M, M) Randomized Phase 2 Study
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Brenner, The University of Texas Health Science Center at San Antonio
- Investigators
- Andrew J Brenner, MD, PhD, Principal investigator, The University of Texas Health Science Center at San AntonioEva M Galvan, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470606
- Sponsor's protocol ID
- CTMS# 25-0146
- Acronym
- MemoryRT
- Status last verified
- Sep 2026
- First submitted
- 9 Mar 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data may be shared with groups involved in overseeing this research study including monitors, data safety monitoring committee, any law enforcement agencies, the IRB or any state or local health departments. Any de-identified results will be submitted for publication in a peer reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory RT: Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the Brain
- ClinicalTrials.gov ID
- NCT07470606
- Acronym / sponsor ID
- MemoryRT / CTMS# 25-0146
- Conditions
- Brain Tumor
- Keywords
- Radiation therapy, Solid tumor cancer, Intensity modulated radiation therapy (IMRT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigators are testing to see if patients receiving radiation treatment for brain cancer along with raloxifene plus memantidine take longer to develop memory issues.
The study will include anyone over the age of 18 who will be treated with radiation for brain cancer.
Detailed description
As cognitive decline is a common side effect after external beam radiation therapy to the brain, estrogen receptor beta (ERβ) modulation presents an unexploited target for mitigating this adverse effect as well.
The investigators seek to address two scientific questions to improve quality of life in patients and improve cancer outcomes: 1) can estrogen modulation further augment neuroprotection achieved by memantine after radiation therapy to the brain? and 2) can estrogen modulation lead to measurable tumor control improvement and molecular changes in CNS malignancies?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a Single-Institution, Open-Label, Prospective, 2-Group (R+M, M) Randomized Phase 2 Study
| Arm | Type | Receives |
|---|---|---|
| Group A: Standard of Care | Active comparator | Drug: MemantinePatients will start Memantine as SOC around the time of radiation. Memantine may be continued as SOC as prescribed by the treating physician after the 24 weeks. |
| Group B: Standard of Care plus raloxifene | Experimental | Drug: Memantine, Drug: RaloxifenePatients will start Memantine as SOC around the time of radiation. Memantine may be continued as SOC as prescribed by the treating physician after the 24 weeks. If randomized to group B patients will be recommended to start the assigned Raloxifene at least one week before their anticipated RT treatment start date. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Ability to provide informed written consent in either English or Spanish.
- All individuals of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an Intrauterine device (IUD)) with their partner from entry into the study through 24 weeks after the last dose of Raloxifene.
- Patients undergoing radiation therapy to the brain as a part of solid tumor cancer therapy, using intensity modulated radiation therapy (IMRT) or whole brain radiation therapy (WBRT).Willingness to adhere to planned study drug regimen, including obtaining medication from an outside pharmacy via prescription.
- Patients must have a creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault Equation).
Key exclusion criteria (8 listed)
- History of prior radiotherapy to the brain.
- Life expectancy of < 6 months.
- Radiation Therapy planned is ≤ 5 fractions (e.g.stereotactic radiosurgery (SRS)or Steriotactic radiotherapy (SRT), or 5-fraction whole brain).
- Contraindications to taking memantine and/or raloxifene based on package inserts and the clinical judgement of the treating physician .
- The subject is unable to undergo magnetic resonance imaging (MRI) scan (e.g., has an MRI incompatible pacemaker).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemantineAlso: NamendaThe goal dose for Immediate Release Memantine is 10 mg oral twice daily. The goal-dose for Extended-Release Memantine is 21 mg daily. | Drug | Group A: Standard of Care, Group B: Standard of Care plus raloxifene |
| RaloxifeneAlso: EvistaRaloxifene will be administered at 120mg orally every day | Drug | Group B: Standard of Care plus raloxifene |
Primary outcome
Hippocampal volume changes
Time frame: Baseline to 48 weeks
MRIs will be used to capture any changes in hippocampal volume
12 secondary outcomes
Eastern Cooperative Oncology Group Performance Status score
Time frame: Baseline to study termination visit (approximately 48 weeks)
Hopkins Verbal Learning Test Revised (HLVT-R) Score
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Trail Making Test -A (TMT-A) Score
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Trail Making Test -B (TMT-B) Score
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Controlled Oral Word Association (COWA) Test Score
Time frame: Week 0 to study termination visit (approximately 48 weeks)
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Brain (BN)tumor-20
Time frame: Week 0 to study termination visit (approximately 48 weeks)
MD Anderson Symptom Inventory Brain Tumor (MDASI-BT)
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Medical Outcomes Study - Cognitive Function (MOS-CF)
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Patient Reported Outcomes Measurement Information System - Cognitive Function (PROMIS-CF)
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Hopkins Verbal Learning Test Revised HLVT-R DR
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Hopkins Verbal Learning Test Revised HLVT-R RECOG
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data may be shared with groups involved in overseeing this research study including monitors, data safety monitoring committee, any law enforcement agencies, the IRB or any state or local health departments. Any de-identified results will be submitted for publication in a peer reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew J Brenner, MD, PhD principal investigator
The University of Texas Health Science Center at San Antonio
Eva M Galvan, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Memantine and Raloxifene in people with Brain Tumor, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew J Brenner, MD, PhD (210-562-4090, brennera@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hippocampal volume changes (time frame: Baseline to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.